Turisco Fran, Keogh Diane, Stubbs Connie, Glaser John, Crowley William F
Emerging Practices First Consulting Group, Boston, MA, USA.
J Investig Med. 2005 Dec;53(8):425-33. doi: 10.2310/6650.2005.53806.
Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.
关于将信息技术（IT）融入美国学术医疗中心（AHC）临床研究流程的信息很少。因此，我们询问了37家领先的AHC，了解它们在临床研究IT方面的现状和未来计划。该调查特别询问了基本基础设施和IT支持要求的有无；支持研究准备、研究实施及其管理支持所需的个人应用程序；以及基础研究、临床试验和医疗服务中日益使用的临床信息系统的数据整合情况。在37家AHC中，78%做出了回应。所有人都强烈认为，“最先进的”临床研究IT计划在今天是理想的，在明天将是必不可少的。尽管如此，目前没有一家AHC拥有哪怕接近这一理想的IT解决方案。没有一家AHC报告拥有启动和持续成功实施一个连贯的临床研究IT平台所需的所有基本管理基础（即连贯的愿景、总体战略、治理结构和专用预算）。许多机构在临床研究IT的个别方面取得了突破，例如不良事件报告系统或同意书模板。然而，支持临床研究的IT的整体实施不均衡且不足。这些数据表明美国领先的AHC在临床研究IT投资方面存在巨大差距。以有意义的方式将临床研究IT企业与其临床运营联系起来仍然是AHC的一个关键战略目标。如果AHC要继续充当我们社会所期望的“转化研究引擎”，就必须认识到这一差距，并分配大量资源来弥补这种情况。
